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(216 days)
The Llis and VITTRA APS composite is suitable for use in:
- Direct restorations in anterior and posterior teeth (I, II, III, IV, V e VI);
- Core build-ups;
- Teeth splinting;
- Indirect restorations such as inlays, onlays and veneers.
- Direct veneers with composites;
- Restoration of deciduous teeth
- Diastema closing or reduction;
- Modification of teeth's shape (e.g .: conoid teeth);
- Cementation of tooth fragments;
- Porcelain/composite repairs:
Llis is a radiopaque composite for anterior and posterior restorations. Its composition was based in modern concepts so that methacrylate monomers, silanes and fillers with adequate size distribution were combined to produce a product with differentiated physical, mechanical and optical properties. Llis presents a simplified shade system, offering enamel, dentin and incisal shades.
Vittra APS is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth. The composite is radiopaque; its loading particles are composed by spheres of a zirconia complex with average load particle size of 200nm, with total inorganic load of 72% to 82% in weight (52% to 60% in volume). Those characteristics contribute to enhance both mechanical and aesthetic properties, especially evidenced by how easy it is to obtain proper polishing and by the long-lasting surface shining. Vittra APS' formula is free of Bis-GMA and Bis-EMA, following the present trend of products free of Bisphenol A (BPA).
APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photoinitiators that interact among each other amplifying the curing capacity of light emitted from light-curing units. Added to different materials, the system provides different advantages.
In the case of Vittra APS, APS adds as main benefit the reduction or elimination of visual shade and opacity alteration before/after light curing, which enhances the predictability of the result. Another factor is that, although there is very little concentration of camphorquinone - that has a yellowish aspect - APS has great power of polymerization allowing greater degree of conversion. The APS system is activated by any type of lightcuring unit available on the market, even those with less power or narrow range of wavelength.
The Dentscare LTDA Llis and VITTRA APS devices are tooth shade resin materials. The provided text outlines the acceptance criteria and study results for these devices.
Acceptance Criteria and Device Performance (Llis and Vittra APS)
The acceptance criteria are generally defined by compliance with ISO 4049 (Dentistry - Polymer-based restorative materials) and in some cases, by comparison to commercially available, internationally recognized quality composites.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Llis | ||
| Sensitivity to environment lighting | Physical homogeneity after testing, with no difference compared to material pressed between coverslips without ambient light exposure (ISO 4049). | All results are within the range specified by ISO 4049. |
| Depth of Cure | > 1.0 mm for opaque materials and > 1.5 mm for non-opaque materials (ISO 4049). | All results are greater than the specified threshold, conforming to the standard. (Llis: 2.44 mm; Vittra APS: 2.43 mm reported in Section J. The individual test result for Vittra APS is also stated as "All results are greater than the specified threshold"). |
| Color tone stability after radiation and water absorption | No more than a small change in color, and three observers with normal vision identify no differences in color after visual inspection at 200-300 mm distance for <2 seconds in a Day Light - D65 mode light chamber, with a white (90% reflectance) background and gray (30 ± 5% reflectance) surround (ISO 4049 and ISO 7491). | All comparisons were carried out by three observers with normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician. They did not attest to any color difference in the samples analyzed. The results demonstrate that the product meets ISO 4049. |
| Radiopacity | Compare individual optical drives of each aluminum scale against the density of each scale using ISO 4049 as reference, determining the corresponding aluminum value. | The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according to the requirements of ISO 4049. (Llis: 1.98 mm; Vittra APS: 2.31 mm reported in Section J. The individual test result for Vittra APS also states "The values found in the specimens are between the second and third scale of the aluminum part"). |
| Flexing Resistance (Flexural Strength) | ≥80MPa (EN ISO 4049). | All results are greater than the specified threshold, conforming to the standard. (Llis: 138.8 MPa; Vittra APS: 142.6 MPa reported in Section J. The individual test result for Vittra APS states "All results are greater than the specified threshold", furthermore, "Vittra APS has excellent bending resistance, statistically comparable or superior to products already well known in the market"). |
| Water sorption and solubility | Sorption: Maximum of 40 µm/mm³. Solubility: maximum of 7.5 μm/mm³ (EN ISO 4049). | The results demonstrate that the product complies with the specification in EN ISO 4049 Standard. (Llis sorption: 16.32 µg/mm³, solubility: 4.78 µg/mm³; Vittra APS sorption: 15.55 µg/mm³, solubility: 4.06 µg/mm³ reported in Section J). |
| Accelerated Stability Studies | Study created to accelerate possible chemical degradation and/or physical changes in forced storage conditions, confirming a 3-year shelf-life at 30°C. | Considering the results observed at the end of the 274 days test period, the shelf-life of 3 years in the storage condition of 30 °C for the product can be confirmed. |
| Evaluation Report Of Long-Term Stability (Shelf) | Study designed to verify physical and chemical characteristics during expected shelf life, confirming expiration date and storage conditions, for a 3-year shelf-life. | Considering the results observed at the end of the 36 months of the long-term test (shelf), the shelf life of 3 years in the storage condition of 30°C for the product can be confirmed. |
| Vittra APS (Additional Tests) | ||
| Color change during polymerization | Statistically ≤ than competing commercially available, internationally recognized quality composites. | Vittra APS showed the least change in color, being similar to the resins Estelite Quick (Tokuyama) and Filtek Z350 XT (3M ESPE). |
| Knoop hardness | Statistically ≥ than competing commercially available, internationally recognized quality composites. | Vittra APS showed greater surface hardness among the composites that participated in the trial, showing surprising such values. This originates from the quality, morphology, and content of the loads used, as well as the quality of the polymers formed and its integration with those loads. |
| Conversion rate | Statistically ≥ than competing commercially available, internationally recognized quality composites. | Vittra APS showed a conversion degree statistically equal to the best results of the other materials under analysis within a considered range. The excellent mechanical results demonstrated are an evidence for that observation. |
| Elasticity Module | Mean equal to or slightly less than that of human dentin (10-15 GPa). | Vittra APS showed an elasticity module superior to the one of resins Estelite Quick (Tokuyama Dental) and Tetric N-Ceram (Ivoclar Vivadent), being compatible to the lowest limiting value that is attributed to the human dentine. |
| Compressive Strength | Statistically ≥ than competing commercially available, internationally recognized quality composites. | It is noticeable that Vittra APS showed compressive strength statistically equal to the best results of the other materials under analysis. |
| Roughness before and after simulated brushing | Statistically ≤ than competing commercially available, internationally recognized quality composites. | Vittra APS was the only composite that did not show increase in surface roughness after simulated brushing. The result demonstrates high resistance to abrasion, reflecting properties expected due to its high Knoop Hardness value. Practically, Vittra APS showed an increase in smoothness, explaining the long-lasting maintenance of its shine. |
| Fracture Toughness | Statistically ≥ than competing commercially available, internationally recognized quality composites. | Vittra APS showed fracture toughness statistically equal to the best results of the other materials under analysis. |
Study Information for Llis and VITTRA APS
The studies mentioned are non-clinical tests conducted to assess the physical and chemical properties of the devices.
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Sample size used for the test set and the data provenance:
- The specific sample sizes for each test (e.g., number of specimens for depth of cure, flexural strength) are not explicitly stated in the provided text, beyond the mention of "samples analyzed" or "specimens."
- The data provenance for some Vittra APS tests (Color change during polymerization, Knoop hardness, Conversion rate, Elasticity Module, Compressive Strength, Flexural Resistance, Roughness before and after simulated brushing, Fracture Toughness) is identified as studies carried out at "Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão." This suggests the data is likely retrospective lab-based testing.
- For the standard ISO tests for both Llis and Vittra APS, the text refers to "All results are within the range specified by ISO 4049" or "All results are greater than the specified threshold," implying in-house lab testing for current product batches. The country of origin for Dentscare LTDA is Brazil.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Color tone stability after radiation and water absorption test for both Llis and Vittra APS, three observers were used.
- Qualifications: They possessed "normal eyesight" and were "certified by a competent physician."
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Adjudication method for the test set:
- For the Color tone stability test, the acceptance criterion specifically states that "three observers with normal vision, who do not identify any differences in color" must make the comparison. This implies a unanimous consensus among the three certified experts for acceptance.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving human readers or AI assistance is mentioned. The devices are dental restorative materials, and the testing focuses on their physical and chemical properties, not diagnostic or interpretive effectiveness.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. These are physical dental restorative materials, not algorithmic software devices.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Consensus: For the "Color tone stability after radiation and water absorption" test, the ground truth was established by the consensus of three certified observers regarding color difference.
- Standard Specifications/Reference Values: For most other tests (e.g., Depth of Cure, Flexural Strength, Water Sorption, Radiopacity), the ground truth is based on the quantitative specifications outlined in international standards like ISO 4049 or comparison to known reference materials (e.g., aluminum scale for radiopacity, human dentin for elasticity module).
- Comparative Performance: For some Vittra APS-specific tests (color change during polymerization, Knoop hardness, conversion rate, compressive strength, roughness, fracture toughness), the ground truth was defined by criteria relative to the performance of "commercial composites of internationally recognised quality."
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The descriptions are for physical material testing.
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How the ground truth for the training set was established:
- Not applicable.
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